Oral care compositions

ABSTRACT

An oral care composition, including a non-aqueous dispersant and a fatty acid structure-building agent.

BACKGROUND

Generally, structure-building agents, also referred to as gellingagents, thickening agents, or thickeners are used in oral carecomposition to increase a viscosity of the oral care composition and toprovide a structure to hold other ingredients of the oral carecomposition in a homogenous state or in a chemically and/or physicallystable environment.

Structure-building agents may be hydrophilic or hydrophobic. Hydrophilicgelling agents, such as polyvinylpyrrolidone (PVP), Carbopol, etc., areused to provide a homogenous structure for aqueous products, whilehydrophobic gelling agents, such as plastic gels, are used for productscontaining large amount of a hydrophobic oil, e.g., mineral oil.However, conventional structure-building agents, such as PVP, Carbopol,plastic gels, etc., are not able to provide a fully homogenous structureto oral care compositions when the oral care composition includessignificant amounts of non-aqueous liquids used as dispersants.

Accordingly, there is a desire for structure-building agents that canprovide a stable and homogeneous structure to oral care compositionsthat include non-aqueous liquids.

BRIEF SUMMARY

This section is intended merely to introduce a simplified summary ofsome aspects of one or more embodiments of the present disclosure.Further areas of applicability of the present invention will becomeapparent from the detailed description provided hereinafter. Thissummary is not an extensive overview, nor is it intended to identify keyor critical elements of the present teachings, nor to delineate thescope of the disclosure. Rather, its purpose is merely to present one ormore concepts in simplified form as a prelude to the detaileddescription below.

The foregoing and/or other aspects and utilities of the presentdisclosure may be achieved by providing an oral care composition,including from about 0.01% to about 99% of a non-aqueous dispersant,based on the total weight of the oral care composition, and from about0.01% to about 60% of a fatty acid structure-building agent, based onthe total weight of the oral care composition, wherein the fatty acidstructure-building agent comprises 12-HSA.

The non-aqueous dispersant may include a non-aqueous liquid selectedfrom the group consisting of glycerin monoacetate, triacetin, diethyleneglycol diacetate, ethylene glycol diacetate, and propylene glycoldiacetate (PGDA).

The non-aqueous dispersant may include a liquid poloxamer or a pastepoloxamer.

The fatty acid structure-building agent may consist essentially of12-HSA.

The non-aqueous liquid may include triacetin.

The non-aqueous liquid may include PGDA.

The non-aqueous liquid may consist essentially of triacetin or PGDA.

A viscosity of the oral care composition may be from about 10,000 toabout 500,000 cPs.

The oral care composition may further include at least one orallyacceptable ingredient from the group consisting of: a whitening agent, asurfactant, an antioxidant, a flavoring, a sweetener, a pH modifiers, anabrasive, an anticalculus agent, a source of fluoride ions, a stannousion source, a colorant, a dye, and a pigment.

The oral care composition may be a dentifrice.

The non-aqueous dispersant may include a low water content dispersant.

The oral care composition may include from about 20 weight % to about 80weight % of a non-aqueous dispersant; and from about 1 weight % to about30 weight % of fatty acid structure-building agent, wherein thenon-aqueous dispersant may include at least one of glycerin monoacetate,triacetin, diethylene glycol diacetate, ethylene glycol diacetate, andpropylene glycol diacetate (PGDA), and wherein the fatty acidstructure-building agent may consist essentially of 12-HSA.

The oral care composition may include an equal or greater amount ofnon-aqueous dispersant to fatty acid structure-building, such that amass ratio of the non-aqueous dispersant to the fatty acidstructure-building is 50:50 or greater.

A mass ratio of the non-aqueous dispersant to the fatty acidstructure-building may be from about 2 to 50:1.

A mass ratio of the non-aqueous dispersant to the fatty acidstructure-building may be from about 5 to 50:1.

A mass ratio of the non-aqueous dispersant to the fatty acidstructure-building may be from about 2 to 20:1.

The foregoing and/or other aspects and utilities of the presentdisclosure may also be achieved by providing an oral care composition,including from about 0.01% to about 99% of a non-aqueous liquid, basedon the total weight of the oral care composition, and from about 0.01%to about 60% of fatty acid structure-building agent, based on the totalweight of the oral care composition, wherein the non-aqueous liquid mayinclude at least one of glycerin monoacetate, triacetin, diethyleneglycol diacetate, ethylene glycol diacetate, and propylene glycoldiacetate (PGDA), wherein the fatty acid structure-building agent mayinclude 12-HSA, and wherein the oral care composition may include anequal or greater amount of non-aqueous liquid to fatty acidstructure-building agent, such that a mass ratio of the non-aqueousliquid to the fatty acid structure-building agent is 50:50 or greater.

The fatty acid structure-building agent may consist essentially of12-HAS.

The non-aqueous liquid may include triacetin, and a mass ratio of thenon-aqueous liquid to the fatty acid structure-building may be about9:1.

The non-aqueous liquid may include PGDA, and a mass ratio of thenon-aqueous liquid to the fatty acid structure-building may be about4:1.

The foregoing and/or other aspects and utilities embodied in the presentdisclosure may be achieved by providing an oral care compositionsubstantially as hereinbefore described, with reference to the examplesand excluding, if any, comparative examples.

DETAILED DESCRIPTION

The embodiments are described below to provide a more completeunderstanding of the components, processes, compositions, andapparatuses disclosed herein. Any examples given are intended to beillustrative, and not restrictive. However, it will be apparent to oneof ordinary skill in the art that the invention may be practiced withoutthese specific details. In other instances, well-known methods,procedures, and components have not been described in detail so as notto unnecessarily obscure aspects of the embodiments.

Throughout the specification and claims, the following terms take themeanings explicitly associated herein, unless the context clearlydictates otherwise. The phrases “in some embodiments” and “in anembodiment” as used herein do not necessarily refer to the sameembodiment(s), though they may. Furthermore, the phrases “in anotherembodiment” and “in some other embodiments” as used herein do notnecessarily refer to a different embodiment, although they may. Asdescribed below, various embodiments may be readily combined, withoutdeparting from the scope or spirit of the present disclosure.

As used herein, the term “or” is an inclusive operator, and isequivalent to the term “and/or,” unless the context clearly dictatesotherwise. The term “based on” is not exclusive and allows for beingbased on additional factors not described, unless the context clearlydictates otherwise. In the specification, the recitation of “at leastone of A, B, and C,” includes embodiments containing A, B, or C,multiple examples of A, B, or C, or combinations of A/B, A/C, B/C,A/B/B/B/B/C, A/B/C, etc. In addition, throughout the specification, themeaning of “a,” “an,” and “the” include plural references. The meaningof“in” includes “in” and “on.”

It will also be understood that, although the terms first, second, etc.may be used herein to describe various elements, these elements shouldnot be limited by these terms. These terms are only used to distinguishone element from another. For example, a first object, component, orstep could be termed a second object, component, or step, and,similarly, a second object, component, or step could be termed a firstobject, component, or step, without departing from the scope of theinvention. The first object, component, or step, and the second object,component, or step, are both, objects, component, or steps,respectively, but they are not to be considered the same object,component, or step. It will be further understood that the terms“includes,” “including,” “comprises” and/or “comprising,” when used inthis specification, specify the presence of stated features, steps,operations, elements, and/or components, but do not preclude thepresence or addition of one or more other features, steps, operations,elements, components, and/or groups thereof. Further, as used herein,the term “if” may be construed to mean “when” or “upon” or “in responseto determining” or “in response to detecting,” depending on the context.

All physical properties that are defined hereinafter are measured at 20°to 25° Celsius unless otherwise specified.

When referring to any numerical range of values herein, such ranges areunderstood to include each and every number and/or fraction between thestated range minimum and maximum, as well as the endpoints. For example,a range of 0.5-6% would expressly include all intermediate values of,for example, 0.6%, 0.7%, and 0.9%, all the way up to and including5.95%, 5.97%, and 5.99%, among many others. The same applies to eachother numerical property and/or elemental range set forth herein, unlessthe context clearly dictates otherwise.

Unless otherwise specified, all percentages and amounts expressed hereinand elsewhere in the specification should be understood to refer topercentages by weight. The amounts given are based on the active weightof the material.

Additionally, all numerical values are “about” or “approximately” theindicated value, and take into account experimental error and variationsthat would be expected by a person having ordinary skill in the art. Itshould be appreciated that all numerical values and ranges disclosedherein are approximate values and ranges, whether “about” is used inconjunction therewith.

With regard to procedures, methods, techniques, and workflows that arein accordance with some embodiments, some operations in the procedures,methods, techniques, and workflows disclosed herein may be combinedand/or the order of some operations may be changed.

According to one embodiment, an oral care composition may include astructure-building agent and a non-aqueous dispersant. In someembodiments, the non-aqueous dispersant includes a non-aqueous liquid.As used herein, the term “non-aqueous” or “non-aqueous liquid” refers toa substance, or mixture of substances, that has a moisture content of 5%or less by weight.

In some embodiment, the partition coefficient value (log P) may be usedto determine the amphiphilic characteristics of an ingredient. Forexample, the partition coefficient value may be used as a measure oflipophilicity. Large positive log P values indicate a lipophilic orhydrophobic nature, whereas, large negative log P value indicate alipophobic or hydrophilic nature. In some embodiments, the non-aqueousliquid has a log P value of about −2 to about +2.

In one embodiment, the dispersant is non-aqueous, but the dispersant issufficiently hydrophilic to react in an aqueous environment.

In one embodiment, the non-aqueous dispersant is a poloxamer. In someembodiments, the non-aqueous dispersant is a liquid or paste likepoloxamer, with average molecular weight less than 7000 Dalton. Forexample, the dispersant may include one or more of Pluronic® L35,Pluronic® L43, Pluronic® L64, Pluronic® L10, Pluronic® L44, Pluronic®L62, Pluronic® 10R5, Pluronic® 17R4, Pluronic® L25R4, Pluronic® P84,Pluronic® P65, Pluronic® P104, and Pluronic® P105. Pluronic® branddispersants are commercially available from BASF, Florham Park, N.J.

In one embodiment, the oral care composition includes from about 0.01%to about 99%/non-aqueous dispersant based on the total weight of theoral care composition. In another embodiment, the oral care compositionincludes from about 1 weight % to about 70 weight % non-aqueousdispersant. In yet another embodiment, the oral care compositionincludes from about 5 weight % to about 50 weight % non-aqueousdispersant. For example, in one embodiment, the oral care compositionincludes from about 0.01 weight % to about 99 weight % L35, from about 1weight % to about 70 weight % L35, or from about 5 weight % to about 50weight % L35.

In other embodiments, the oral care composition includes one or morenon-aqueous liquids as non-aqueous dispersants or liquid carriers. Insome embodiments, the non-aqueous liquid is a hydrophobic non-aqueousliquid.

In some embodiments, the structure-building agent is combined with oneor more non-aqueous liquids to create a gel. For example, in someembodiments, the oral care composition may include a gel formed fromcombining a structure-building agent with one or more of glycerinmonoacetate, triacetin, diethylene glycol diacetate, ethylene glycoldiacetate, and propylene glycol diacetate (PGDA) as a non-aqueousliquid. Triacetin is commercially available as Glyceryl triacetate, fromSpectrum Chemical MFG Corp. Propylene Glycol Diacetin (PGDA) iscommercially available from Sigma-Aldrich Corp.

In one embodiment, the oral care composition includes from about 0.01%to about 99% non-aqueous liquid(s) based on a total weight of the oralcare composition. In another embodiment, the oral care compositionincludes from about 1 weight % to about 70 weight % non-aqueousliquid(s). In yet another embodiment, the oral care composition includesfrom about 5 weight % to about 50 weight % non-aqueous liquid(s). Forexample, in one embodiment, the oral care composition includes fromabout 0.01 weight % to about 99 weight % triacetin, from about 1 weight% to about 70 weight % triacetin, or from about 5 weight % to about 50weight % triacetin. In one example, the oral care composition includesabout 26 weight % triacetin based on the total weight of the oral carecomposition. In other embodiments, the oral care composition includesfrom about 0.01 weight % to about 99 weight % PGDA, from about 1 weight% to about 70 weight % PGDA, or from about 5 weight % to about 50 weight% PGDA.

Oral care compositions may comprise a structure-building agent capableof holding other ingredients of the oral care composition in ahomogenous state or in a chemically and/or physically stableenvironment. However, conventional structure-building agents, such aspolyvinylpyrrolidone (PVP), Carbopol, plastic gels, etc., are not ableto provide a homogenous structure to oral care compositions when theoral care composition includes significant amounts of non-aqueousliquids. Instead, when the oral care composition containing conventionalstructure-building agents is mixed into a gel with non-aqueous liquids,physical separation of the gel normally occurs within a few hours afterthe gel is made.

Accordingly, in some embodiments, the oral care composition may alsoinclude one or more fatty acid structure-building agents capable ofcreating a stable and homogenous gel with non-aqueous dispersants ornon-aqueous liquids in the oral care composition.

As used herein, the term structural builder or structure-building agentrefers to a material, or combination of materials, that not only maythicken the oral care composition, but may also maintain the oral carecomposition in a homogenous state. That is, a state where phaseseparation is minimized over time. In addition, in some embodiments, thestructure-building agent may affect the viscosity of the oral carecomposition.

In one embodiment, the structure-building agent is able to form a gelstructure by self-assembly. For example, the structure-building agentmay be able to form a gel structure to trap the non-aqueous liquid inits internal structure via hydrogen bonding.

According to one embodiment, the structure-building agent may include12-hydroxystearic acid (12-HSA). 12-HSA is commercially fromSigma-Aldrich Corp.

In one embodiment, the oral care composition includes from about 0.01%to about 99% non-aqueous liquid and from about 0.01% to about 60%structure-building agent, based on the total weight of the oral carecomposition. In another embodiment, the oral care composition includesfrom about 1 weight % to about 70 weight % non-aqueous liquid and fromabout 1 weight % to about 50 weight % structure-building agent. In yetanother embodiment, the oral care composition includes from about 5weight % to about 50 weight % non-aqueous liquid and from about 5 weight% to about 40 weight % structure-building agent. For example, in oneembodiment, the oral care composition includes from about 50 weight % toabout 95 weight % triacetin and from about 1 weight % to about 30 weight% 12-HSA, or from about 60 weight % to about 90 weight % triacetin andfrom about 1 weight % to about 20 weight % 12-HSA.

In other embodiments, the amount of non-aqueous liquid andstructure-building agent may be defined as a ratio. For example, in oneembodiments, the oral care composition includes a mass ratio of 9:1 ofthe non-aqueous liquids to structure-building agent. In otherembodiments, the non-aqueous liquid to structure-building agent massratio is from about 2 to 50:1 or of about 5 to 50:1. For example, insome embodiments, the oral care composition may be formed of a gelhaving a 9:1 triacetin:12-HSA mass ratio. In other embodiments, the oralcare composition may be formed of a gel having a 4:1 PGDA:12-HSA massratio. In some embodiments, the gel has about a 2 to 20:1 PGDA: 12-HSAmass ratio.

Generally, viscosity is an important parameter for oral carecompositions, such as toothpastes or whitening gels. For example, whenthe viscosity of an oral care composition is too low, it may become toorunny and physical phase separation may take place. In some cases, thiswill not only affect the aesthetics of the oral care composition butalso the homogeneity of the ingredients in the oral care composition. Onthe other hand, if the viscosity of the oral care compositions is toohigh, the oral care composition will be difficult to manufacture andpackage. In addition, oral care compositions with high viscosity arevery difficult for users to evacuate from commonly used packages, suchas tubes or syringes. In some embodiments, the gel formed of thestructural building agent and the non-aqueous liquids helps determinethe overall viscosity of the oral care composition. Accordingly, it'simportant to select ingredients for oral care compositions that achievea desirable range of viscosity to ensure product manufacturability,stability, and quality, as well as consumer acceptance.

In some embodiments, the viscosity of the oral care composition is fromabout 10,000 centipoise (cPs) to about 500,000 cPs at 25° C. In otherembodiments, the viscosity of the oral care composition is from about50,000 cPs to about 400,000 cPs at 25° C. In one embodiment, theviscosity of the oral care composition is from about 125,000 cPs toabout 300,000 cPs at 25° C.

According to some embodiments, the structure-building agent is capableof creating a stable and homogenous gel with the non-aqueous liquids inan oral care composition. For example, a homogenous and transparent orsemi-transparent gel can be created from combining a fatty acidstructure-building agents, such as 12-HSA, with a non-aqueous liquiddispersant, such as triacetin, diacetin, propylene glycol diacetin, etc.

In some embodiments, the oral care composition may include additionalingredients common to oral care compositions, such as additionaldispersants, whitening agents, flavoring agents, tartar control agents,surfactants, sweeteners, humectants, colorants, dyes, and pigments.

All ingredients used in the compositions described herein should beorally acceptable. “Orally acceptable” means an ingredient which ispresent in the composition as described in an amount and form which doesnot render the composition unsafe, unpalatable, or otherwise unsuitablefor use in the oral cavity.

In some embodiments, the oral care composition includes a combination ofnon-aqueous or suitable low water content dispersants in addition to apoloxamer and/or a non-aqueous liquid. For example, in some embodiments,the oral care composition may include one or more of polyethyleneglycols, such as PEG400 and PEG600, or polyethylene/polypropylene glycolcopolymers, such as PEG/PPG 38/8 and PEG/PPG-116/66.

As described above, the oral care composition includes one or morewhitening agent. As used herein, a “whitening agent” is a material whicheffects whitening of a tooth surface to which it is applied. Forexample, in some embodiments, the whitening agent is an oxidizing agent.In its broadest sense, “oxidizing agent” is intended to include thosecompounds which can accept an electron from another molecule in theenvironment of the oral cavity without having a deleterious orunacceptably harmful effect on the oral cavity in normal and accepteduse.

In some embodiments, the whitening agent may include peroxides andhydroperoxides, such as hydrogen peroxide, peroxides of alkali andalkaline earth metals, organic peroxy compounds, peroxy acids, saltsthereof, and mixtures thereof. Peroxides of alkali and alkaline earthmetals include lithium peroxide, potassium peroxide, sodium peroxide,magnesium peroxide, calcium peroxide, barium peroxide, and mixturesthereof. Organic peroxy compounds include urea peroxide, carbamideperoxide (also known as urea hydrogen peroxide), glyceryl hydrogenperoxide, alkyl hydrogen peroxides, dialkyl peroxides, alkyl peroxyacids, peroxy esters, diacyl peroxides, benzoyl peroxide, andmonoperoxyphthalate, and mixtures thereof. Peroxy acids and their saltsinclude organic peroxy acids such as alkyl peroxy acids, andmonoperoxyphthalate and mixtures thereof, as well as inorganic peroxyacid salts such as percarbonate, perphosphate, perborate and persilicatesalts of alkali and alkaline earth metals such as lithium, potassium,sodium, magnesium, calcium and barium, and mixtures thereof. In someembodiments a non-peroxide whitening agent may be provided. Whiteningagents among those useful herein include non-peroxy compounds, such aschlorine dioxide, chlorites and hypochlorites. Chlorites andhypochlorites include those of alkali and alkaline earth metals such aslithium, potassium, sodium, magnesium, calcium and barium. Non-peroxidewhitening agents also include colorants, such as titanium dioxide andhydroxyapatite.

In some embodiments, the oral care composition includes from about 0.01%to about 50% whitening agent based on a total weight of the oral carecomposition. In other embodiments, the oral care composition includesfrom about 0.05 weight % to about 40 weight % whitening agent. In oneembodiment, the oral care composition includes about 0.1 weight %whitening agent based on a total weight of the oral care composition.

In one embodiment, the oral care composition includes one or moresurfactants. In some embodiments, the surfactants enhance stability ofthe composition, help clean the oral cavity surfaces through detergency,and provide foam upon agitation, e.g., during brushing with an oral carecomposition of the disclosure. Surfactants or surface active agentsgenerally achieve increased whitening action by thoroughly dispersingthe whitening agent throughout the oral cavity. In various embodiments,suitable surface active agents may function as a surface active agent,emulsifier, and/or foam modulator.

Any orally acceptable surfactant, most of which are anionic, nonionic,cationic, or amphoteric, can be used. A combination of surfactants mayalso be used. Suitable anionic surfactants include without limitationwater-soluble salts of C₈₋₂₀ alkyl sulfates, sulfonated monoglyceridesof C₈₋₂₀ fatty acids, sarcosinates, taurates and the like. Illustrativeexamples of these and other classes include sodium lauryl sulfate,sodium cocoyl monoglyceride sulfonate, sodium lauryl sarcosinate, sodiumlauryl isoethionate, sodium laureth carboxylate, and sodium dodecylbenzenesulfonate. Suitable nonionic surfactants include withoutlimitation poloxamers, polyoxyethylene sorbitan esters, fatty alcoholethoxylates, alkylphenol ethoxylates, tertiary amine oxides, tertiaryphosphine oxides, dialkyl sulfoxides and the like. Suitable amphotericsurfactants include, without limitation, derivatives of C₈₋₂₀ aliphaticsecondary and tertiary amines having an anionic group such ascarboxylate, sulfate, sulfonate, phosphate or phosphonate. A suitableexample is cocoamidopropyl betaine.

In some embodiments, the oral care composition includes from about 0.01%to about 20.0% surfactant based on a total weight of the oral carecomposition. In other embodiments, the oral care composition includesfrom about 1.0 weight % to about 10.0 weight % surfactant. In oneembodiment, the oral care composition includes about 2 weight %surfactant based on a total weight of the oral care composition. Forexample, the oral care composition may include about 2 weight % sodiumlauryl sulfate.

In other embodiments, the oral care composition may include additionalstructure-building agents. For example, the oral care composition mayinclude a cross-linked polymer, such as cross-linkedpolyvinylpyrrolidone (“PVP”) in addition to the amphiphilic copolymerstructure-building agents, such as PVP-VA. In one embodiment, thestructure-building agent includes cross-linked polymers capable ofinteracting with the dispersants. For example, in some embodiments,cross-linked PVP swells in the presence of poloxamers by absorbing theminto its cross-linked polymer network. Such interaction helps to preventthe solid (cross-linked PVP) from phase separating from the liquiddispersant in the oral care composition.

According to some embodiments, suitable structure-building agentpolymers and copolymers include N-vinyl lactam based polymers andcopolymers. The monomers for preparing a vinyl lactam-based polymer orco-polymer of the present application includes any monomer having 3 to 8atoms in a heterocyclic ring, comprising a carbonyl carbon atom and aheteroatom (such as N, S, O) in its vinyl moiety. Suitable monomersinclude but not limited to N-vinyl-2-pyrrolidone, N-vinyl-2-piperidone,N-vinyl-3-methyl-pyrrolidinone, N-vinyl-3-methyl-piperidone,N-vinyl-3-methyl-caprolactam, N-vinyl-4-methyl-pyrrolidinone,N-vinyl-4-methyl-2-pyrrolidone, N-vinyl-4-methyl-piperidone,N-vinyl-4-methyl-caprolactam, N-vinyl-5-methyl-pyrrolidinone,N-vinyl-5-ethyl-2-pyrrolidone, N-vinyl-4-methyl-piperidone,N-vinyl-3-ethyl-pyrrolidinone, N-vinyl-4,5-dimethyl-pyrrolidinone,N-vinyl-5,5-dimethyl-pyrrolidinone,N-vinyl-3,3,5-trimethyl-pyrrolidinone,N-vinyl-5-methyl-5-ethyl-pyrrolidinone,N-vinyl-3,4,5-trimethyl-3-ethyl-pyrrolidinone,N-vinyl-6-methyl-2-piperidone, N-vinyl-6-ethyl-2-piperidone,N-vinyl-3,5-dimethyl-2-piperidone, N-vinyl-4,4-dimethyl-2-piperidone,N-vinyl-2-caprolactam, N-vinyl-7-methyl-caprolactam,N-vinyl-7-ethyl-caprolactam, N-vinyl-3,5-dimethyl-caprolactam,N-vinyl-4,6-dimethyl-caprolactam, N-vinyl-3,5,7-trimethyl-caprolactam,N-vinyl-2-valerolactam, N-vinyl-hexahydro-2-azepinone,N-vinyl-octahydro-2-azocinone. N-vinyl octahydro-2-azoninone, andN-vinyl decahydro-2-azecinone.

The polymer may be a cross-linked polyvinylpyrrolidone, also known aspoly-N-vinyl-poly-2-pyrrolidone, and commonly abbreviated tocross-linked “PVP.” PVP generally refers to a polymer containingvinylpyrrolidone (also referred to as N-vinylpyrrolidone,N-vinyl-2-pyrrolidione and N-vinyl-2-pyrrolidinone) as a monomeric unit.The monomeric unit may include a polar imide group, four non-polarmethylene groups, and a non-polar methane group. Cross linked PVPincludes those commercially available as KOLLIDON® and LUVICROSS®,marketed by BASF, Mount Olive, N.J., USA; and POLYPLASDONE® INF-10,marketed by, Ashland, Covington, Ky., USA.

In some embodiments, the oral care composition may include additionalthickening agents. Any orally acceptable thickening agent can be used,including without limitation carbomers, also known as carboxyvinylpolymers, carrageenans, also known as Irish moss and more particularlycarrageenan (iota-carrageenan), high molecular weight polyethyleneglycols (such as CARBOWAX™, available from The Dow Chemical Company),cellulosic polymers such as hydroxyethylcellulose,carboxymethylcellulose (“CMC”) and salts thereof, e.g., CMC sodium,natural gums such as karaya, xanthan, gum arabic and tragacanth,colloidal magnesium aluminum silicate, and colloidal or fumed silica andmixtures of the same. The thickening agent may be a combination of oneor more orally acceptable thickening agents.

In some embodiments, the oral care composition includes from about 0.01%to about 30% thickening agent based on a total weight of the oral carecomposition. In other embodiments, the oral care composition includesfrom about 0.1 weight % to about 20 weight % thickening agent. In yetanother embodiment, the oral care composition includes from about 0.5weight % to about 10 weight % thickening agent based on a total weightof the oral care composition. For example, the oral care composition mayinclude about 3 weight % fumed silica.

In some embodiments, the oral care composition includes an antioxidant.Acceptable antioxidants include BHA, BHT, vitamin A, carotenoids,vitamin E, flavonoids, polyphenols, ascorbic acid, herbal antioxidants,chlorophyll, melatonin and mixtures thereof. In some embodiments, theoral care composition includes from about 0.001% to about 1%antioxidants based on a total weight of the oral care composition. Inone embodiment, the oral care composition includes about 0.03 weight %antioxidant by weight.

According to one embodiment, the oral care composition includes one ormore flavoring agent. Useful flavoring agents include any material ormixture of materials operable to enhance the taste of the oral carecomposition. Any orally acceptable natural or synthetic flavoring agentcan be used, such as flavoring oils, flavoring aldehydes, esters,alcohols, similar materials, and combinations thereof. Flavoring agentsinclude vanillin, sage, marjoram, parsley oil, spearmint oil, cinnamonoil, oil of wintergreen (methylsalicylate), peppermint oil, clove oil,bay oil, anise oil, eucalyptus oil, citrus oils, fruit oils and essencesincluding those derived from lemon, orange, lime, grapefruit, apricot,banana, grape, apple, strawberry, cherry, pineapple, etc., bean- andnut-derived flavors such as coffee, cocoa, cola, peanut, almond, etc.,adsorbed and encapsulated flavorants, and mixtures thereof. Alsoencompassed within flavoring agents herein are ingredients that providefragrance and/or other sensory effect in the mouth, including cooling orwarming effects. Such ingredients include menthol, menthyl acetate,menthyl lactate, camphor, eucalyptus oil, eucalyptol, anethole, eugenol,cassia, oxanone, x-irisone, propenyl guaiethol, thymol, linalool,benzaldehyde, cinnamaldehyde, N-ethyl-p-menthan-3-carboxamine,N,2,3-trimethyl-2-isopropylbutanamide, 3-1-menthoxypropane-1,2-diol,cinnamaldehyde glycerol acetal (CGA), methone glycerol acetal (MGA) andmixtures thereof.

In some embodiments, the oral care composition includes from about 0.01%to about 5% flavoring agents based on a total weight of the oral carecomposition. In another embodiment, the oral care composition includesfrom about 0.05 weight % to about 3 weight % flavoring agents. In yetanother embodiment, the oral care composition includes from about 0.1weight % to about 3 weight %, from about 0.2 weight % to about 2.5weight %, or about 1.5 weight % flavoring agents based on a total weightof the oral care composition. For example, the oral care composition mayinclude about 1.5 weight % of dental cream flavor.

In some embodiments, the oral care composition may also include one ormore sweeteners. Sweeteners among those useful herein include orallyacceptable natural or artificial, nutritive or non-nutritive sweeteners.Such sweeteners include dextrose, polydextrose, sucrose, maltose,dextrin, dried invert sugar, mannose, xylose, ribose, fructose,levulose, galactose, corn syrup (including high fructose corn syrup andcorn syrup solids), partially hydrolyzed starch, hydrogenated starchhydrolysate, sorbitol, mannitol, xylitol, maltitol, isomalt, aspartame,neotame, saccharin and salts thereof, sucralose, dipeptide-based intensesweeteners, cyclamates, dihydrochalcones and mixtures thereof. Someembodiments may include one or more sweeteners. In some embodiments, theoral care composition includes from about 0.005% to about 5% sweetenersbased on a total weight of the oral care composition. In otherembodiments, the oral care composition includes from about 0.01% toabout 1% sweeteners. For example, the oral care composition may includeabout 0.5 weight % sodium saccharin and about 0.04 weight % sucralose.

In some embodiments, the oral care composition may also include one ormore pH modifying agents. PH modifying agents among those useful hereininclude acidifying agents to lower pH, basifying agents to raise pH andbuffering agents to control pH within a desired range. For example, oneor more compounds selected from acidifying, basifying and bufferingagents can be included to provide a pH of 2 to 10, or in variousembodiments from about 2 to about 8, from about 3 to about 9, from about4 to about 8, from about 5 to about 7, from about 6 to about 10, andfrom about 7 to about 9. Any orally acceptable pH modifying agent can beused, including without limitation carboxylic, phosphoric and sulfonicacids, acid salts (e.g., monosodium citrate, disodium citrate,monosodium malate, etc.), alkali metal hydroxides such as sodiumhydroxide, carbonates such as sodium carbonate, bicarbonates,sesquicarbonates, borates, silicates, phosphates (e.g., monosodiumphosphate, trisodium phosphate, pyrophosphate salts, etc.), imidazoleand mixtures thereof. One or more pH modifying agents are optionallypresent in a total amount effective to maintain the composition in anorally acceptable pH range. In some embodiments, the oral carecomposition includes from about 0.01% to about 10% pH modifier agentsbased on a total weight of the oral care composition. For example, theoral care composition may include about 0.9 weight % sodium acidpyrophosphate (SAPP) and about 2 weight % tetrasodium pyrophosphate(TSPP) as a pH modifier.

In some embodiments, the oral care composition may include colorants.Colorants, such as dyes or pigments, may be food color additivespresently certified under the Food Drug & Cosmetic Act for use in foodand ingested drugs, including dyes such as FD&C Red No. 3 (sodium saltof tetraiodofluorescein), Food Red 17, disodium salt of6-hydroxy-5-{(2-methoxy-5-methyl-4-sulphophenyl)azo}-2-naphthalenesulfonicacid, Food Yellow 13, sodium salt of a mixture of the mono anddisulphonic acids of quinophtalone or 2-(2-quinolyl) indanedione, FD&CYellow No. 5 (sodium salt of4-p-sulfophenylazo-1-p-sulfophenyl-5-hydroxypyrazole-3 carboxylic acid),FD&C Yellow No. 6 (sodium salt ofp-sulfophenylazo-B-naphtol-6-monosulfonate), FD&C Green No. 3 (disodiumsalt of4-{[4-(N-ethyl-p-sulfobenzylamino)-phenyl]-(4-hydroxy-2-sulfoniumphenyl)-methylene}-[1-(N-ethyl-N-p-sulfobenzyl)-DELTA-3,5-cycl-ohexadienimine],FD&C Blue No. 1 (disodium salt ofdibenzyldiethyl-diamino-triphenylcarbinol trisulfonic acid anhydrite),FD&C Blue No. 2 (sodium salt of disulfonic acid of indigotin) andmixtures thereof in various proportions. Typically, colorants ifincluded are present in very small quantities.

The oral compositions of the present disclosure may also include one ormore other active ingredients, which are operable for the prevention ortreatment of a condition or disorder of hard or soft tissue of the oralcavity, the prevention or treatment of a physiological disorder orcondition, or to provide a cosmetic benefit.

Some embodiments of the present disclosure include a dental abrasive orcombination of dental abrasive agents. As used herein, the term“abrasive” or “abrasive agent” also includes materials commonly referredto as “polishing agents.” Any orally acceptable abrasive can be used,but typically, type, fineness (particle size) and amount of abrasiveshould be selected so that tooth enamel is not excessively abraded innormal use of the composition. Suitable abrasives include withoutlimitation silica (in the form of silica gel, hydrated silica orprecipitated silica), alumina, insoluble phosphates, calcium carbonate,resinous abrasives such as urea-formaldehyde condensation products andthe like.

Among insoluble phosphates useful as abrasives are orthophosphates,polymetaphosphates and pyrophosphates. Illustrative examples aredicalcium orthophosphate dihydrate, calcium pyrophosphate, n-calciumpyrophosphate, tricalcium phosphate, calcium polymetaphosphate andinsoluble sodium polymetaphosphate.

Average particle size of an abrasive, if present, is generally fromabout 0.1 to 100 about μm. For example, in one embodiment, the particlesize is from about 1 to about 80 μm or from about 5 to about 60 μm. Insome embodiments, one or more abrasives are present in an amount of fromabout 0.01% to about 70% by weight, based on the total weight of theoral care composition. In other embodiments, the oral care compositionincludes from about 0.1 weight % to about 60 weight % abrasives. In someembodiments, the abrasive is calcium pyrophosphate. In some embodiments,the oral care composition includes from 0.01 weight % to about 70 weight% calcium pyrophosphate based on a total weight of the oral carecomposition. In another embodiment, the oral care composition includesabout 20 weight % calcium pyrophosphate.

In various embodiments of the present disclosure, the oral carecomposition includes an anticalculus agent. Suitable anticalculus agentsinclude without limitation phosphates and polyphosphates (for examplepyrophosphates), polyaminopropanesulfonic acid (AMPS), hexametaphosphatesalts, zinc citrate trihydrate, polypeptides, polyolefin sulfonates,polyolefin phosphates, diphosphonates. In some embodiments, theanticalculus agent is present in an amount of from about 0.01% to about30% weight based on the total weight of the oral care composition. Insome embodiments, the oral care composition includes a mixture ofanticalculus agents. In some embodiments, tetrasodium pyrophosphate(TSPP) and sodium tripolyphosphate (STPP) are used as the anticalculusagents. In some embodiments, the anticalculus agent includes from 0.1%to 10 weight % TSPP, or about 2 weight % TSPP.

Another component of the present compositions may be a synthetic anionicpolymeric polycarboxylate, which acts as a stabilizer for thepolyphosphate anti-tartar agent and which may help to block access ofpainful or pain-causing materials, such as sugars, to the tooth nerves.

In some embodiments, the oral care composition optionally includes asource of fluoride ions. In some embodiments, the source of fluorideions is selected from: fluoride, monofluorophosphate (MFP), andfluorosilicate salts. In some embodiments, one or more fluorideion-releasing compounds are optionally present in an amount providing atotal of 100 to 20,000 ppm, 200 to 5,000 ppm, or 500 to 2,500 ppm,fluoride ions. If present, in some embodiments, the amount of fluoridesource in the oral care composition ranges from about 0.01% to about 10%by weight, based on the total weight of the oral care composition,typically about 1.1 weight %. For example, in one embodiment, the oralcare composition may include about 0.76 weight % MFP.

The compositions also may include a stannous ion or a stannous ionsource to mitigate calcium loss. Suitable stannous ion sources includewithout limitation stannous fluoride, other stannous halides such asstannous chloride dihydrate, stannous pyrophosphate, organic stannouscarboxylate salts such as stannous formate, acetate, gluconate, lactate,tartrate, oxalate, malonate and citrate, stannous ethylene glyoxide andthe like. In some embodiments, one or more stannous ion sources areincluded in the oral care composition. For example, the oral carecomposition may include from about 0.01% to about 10% stannous ionsource by weight, based on the total weight of the oral carecomposition. In one embodiment, the oral care composition includes fromabout 0.1 weight % to about 7 weight % stannous ion source or from about0.2 weight % to about 5 weight % stannous ion source.

EXAMPLES

Aspects of the present disclosure may be further understood by referringto the following examples. The examples are illustrative, and are notintended to be limiting embodiments thereof. Example 1 illustrates amethod of making a gel by combining a structure-building agent with anon-aqueous liquid. Tables 1 and 2 illustrate the gelling results forthe gels created under Example 1.

Example 1

A gel was created by mixing pre-measured amounts of 12-HSA(Sigma-Aldrich Corp.) with pre-measured amounts of triacetin (Glyceryltriacetate, Spectrum Chemical MFG Corp.) or PGDA (Sigma-Aldrich Corp.).Various mass ratios of the 12-HSA and the triacetin or PDGA were mixedon a stir plate at about 55° C. for about 5-15 minutes.

Table 1 illustrates 3 samples that were prepared with Triacetin:12-HSAmass ratios ranging from 32.3:1 to 9:1.

TABLE 1 12- % Triacetin:12- Sample Triacetin HSA 12- HSA No. (g) (g) HSAmass ratio Results 1 9.7 0.3 3% 32.3:1 Liquid appearance 2 9.5 0.5 5% 19:1 Wax-like structure with liquid separation 3 9.0 1.0 10%    9:1 Waxformed, with no phase separation.

Table 2 shows 3 samples that were prepared with PGDA:12-HSA mass ratiosranging from 19:1 to 4:1.

TABLE 2 12- % PGDA:12- Sample PGDA HSA 12- HSA No. (g) (g) HSA massratio Results 1 9.5 0.5  5% 19:1  Liquid appearance 2 9.0 1.0 10% 9:1Wax-like structure with liquid separation 3 8.0 2.0 20% 4:1 Wax formed,with no phase separation.

As illustrated in Table 1, mixtures containing triacetin become thickeras the amount of 12-HSA increases. A wax-like gel structure startsforming when the mass ratio of triacetin:12-HSA reaches about 19:1, anda wax with no phase separation is formed at a mass ratio of 9:1.

Table 2 illustrates the gelling results of 12-HSA on a slightly morelipophilic ingredient, PGDA, which has a molecular structure similar tothat of triacetin. As illustrated in Table 2, mixtures containing PGDAbecome thicker as the amount of 12-HSA increases. A wax-like gelstructure starts forming when the mass ratio of PGDA:12-HSA reachesabout 9:1, and a wax with no phase separation is formed at a mass ratioof 4:1.

As illustrated in Tables 1 and 2, homogenous gels or waxes with noobservable phase separation can be created by mixing fatty-acidstructure-building agents, such as 12-HSA, with non-aqueous liquids,such as triacetin or PGDA. As illustrated in Tables 1 and 2, gels withno phase separation are formed even when the amount of the non-aqueousliquids is greater than 50%.

In some embodiments, the present disclosure provides methods to applythe oral composition to an oral surface in a human or animal subject.The method may include contacting a tooth surface with an oral carecomposition according to embodiments of the present disclosure. As usedherein “animal subject” includes non-human mammals, such as canines,felines and horses. In one embodiment, the oral care composition iscontacted with an oral surface of the mammalian subject to thereby treator whiten teeth in a highly efficacious manner.

In various embodiments, the oral care composition prepared in accordancewith the present disclosure may be applied regularly to an oral surface,for example on a daily basis, at least one time daily for multiple days,or alternately every second or third day. In some embodiments, the oralcare composition is applied to the oral surfaces from 1 to 3 timesdaily, for at least 2 weeks up to 8 weeks, from four months to threeyears, or more up to a lifetime.

In some embodiments, the oral care composition may be embodied as a geland may be applied directly to the teeth using a delivery device, suchas a pen, a liquid stick having an applicator, such as a felt tip,brush, roller ball, or non-woven pad. In some embodiments, the oral carecomposition is activated once exposed to the aqueous environment of theoral cavity or when exposed directly to water or saliva. In someembodiments, the oral care composition of the present disclosure ismaintained on the surface of the tooth for a plurality of minutes.

In some embodiments, the oral care composition is activated andmaintained on the surface of a tooth for from about 1 minute to about 8hours. In some embodiments, the oral care composition is activated andmaintained on the surface of a tooth for from about 5 minutes to about 4hours. In some embodiments, the oral care composition is activated andmaintained on the surface of a tooth for from about 10 minutes to about120 minutes. In some embodiments, the oral care composition is activatedand maintained on the surface of a tooth for from about 15 minutes toabout 60 minutes. In some embodiments, the oral care composition isactivated and maintained on the surface of a tooth for from about 20minutes to about 45 minutes.

The present disclosure has been described with reference to exemplaryembodiments. Although a limited number of embodiments have been shownand described, it will be appreciated by those skilled in the art thatchanges may be made in these embodiments without departing from theprinciples and spirit of preceding detailed description. It is intendedthat the present disclosure be construed as including all suchmodifications and alterations insofar as they come within the scope ofthe appended claims or the equivalents thereof.

What is claimed is:
 1. An oral care composition, comprising: from about50% to about 99% of a non-aqueous liquid, based on the total weight ofthe oral care composition, and from about 1% to about 20% of a fattyacid structure-building agent, based on the total weight of the oralcare composition, wherein the fatty acid structure-building agentcomprises 12-HSA; and wherein the non-aqueous liquid and the fatty acidstructure-building agent are present in a mass ratio of from about 9:1to about 4:1.
 2. The oral care composition of claim 1, wherein thenon-aqueous liquid comprises a non-aqueous liquid selected from thegroup consisting of glycerin monoacetate, triacetin, diethylene glycoldiacetate, ethylene glycol diacetate, and propylene glycol diacetate(PGDA).
 3. The oral care composition of claim 1, wherein the non-aqueousliquid comprises a liquid poloxamer or a paste poloxamer.
 4. The oralcare composition of claim 1, wherein the fatty acid structure-buildingagent consists essentially of 12-HSA.
 5. The oral care composition ofclaim 2, wherein the non-aqueous liquid comprises triacetin.
 6. The oralcare composition of claim 2, wherein the non-aqueous liquid comprisesPGDA.
 7. The oral care composition of claim 2, wherein the non-aqueousliquid consists essentially of triacetin or PGDA.
 8. The oral carecomposition of claim 1, wherein a viscosity of the oral care compositionis from about 10,000 to about 500,000 cPs.
 9. The oral care compositionof claim 1, further comprising at least one orally acceptable ingredientfrom the group consisting of: a whitening agent, a surfactant, anantioxidant, a flavoring agent, a sweetener, a pH modifier, an abrasive,an anticalculus agent, a source of fluoride ions, a stannous ion source,a colorant, a dye, and a pigment.
 10. The oral care composition of claim1, wherein the oral care composition is a dentifrice.
 11. The oral carecomposition of claim 1, wherein the non-aqueous liquid comprises a lowwater content dispersant.
 12. The oral care composition of claim 1,comprising: from about 80 weight % to about 90 weight % of a non-aqueousliquid; and from about 10 weight % to about 20 weight % of fatty acidstructure-building agent, wherein the non-aqueous liquid comprises atleast one of glycerin monoacetate, triacetin, diethylene glycoldiacetate, ethylene glycol diacetate, and propylene glycol diacetate(PGDA), and wherein the fatty acid structure-building agent consistsessentially of 12-HSA.
 13. The oral care composition of claim 1, whereina mass ratio of the non-aqueous liquid to the fatty acidstructure-building agent is about 9:1.
 14. The oral care composition ofclaim 1, wherein a mass ratio of the non-aqueous liquid to the fattyacid structure-building agent is about 4:1.
 15. An oral carecomposition, comprising: from about 80% to about 97% of a non-aqueousliquid, based on the total weight of the oral care composition, and fromabout 1% to about 20% of fatty acid structure-building agent, based onthe total weight of the oral care composition, wherein the non-aqueousliquid comprises at least one of glycerin monoacetate, triacetin,diethylene glycol diacetate, ethylene glycol diacetate, and propyleneglycol diacetate (PGDA), wherein the fatty acid structure-building agentcomprises 12-HSA, and wherein a mass ratio of the non-aqueous liquid tothe fatty acid structure-building agent is from about 9:1 to about 4:1.16. The oral care composition of claim 15, wherein the fatty acidstructure-building agent consists essentially of 12-HSA.
 17. The oralcare composition of claim 15, wherein the non-aqueous liquid comprisestriacetin, and a mass ratio of the non-aqueous liquid to the fatty acidstructure-building agent is about 9:1.
 18. The oral care composition ofclaim 15, wherein the non-aqueous liquid comprises PGDA, and a massratio of the non-aqueous liquid to the fatty acid structure-buildingagent is about 4:1.